SEEQ™

GUDID 00643169513600

EXT CARDIAC MON SEEQ12 2WK KIT US

MEDTRONIC, INC.

Single-patient intensive/general healthcare physiologic monitoring system Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 00643169513600
• NIH Device Record Key: 19755742-2f6c-4286-bb93-1f0ef5e44b95
• Commercial Distribution Discontinuation: 2018-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SEEQ™
• Version Model Number: SEEQ12
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169513600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133701

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2015-06-10

On-Brand Devices [SEEQ™]

• 00643169513686: EXT CARDIAC MON SEEQ1T TRAN REP US
• 00643169513655: EXT CARDIAC MON SEEQ1E WS EXT US
• 00643169513648: EXT CARDIAC MON SEEQ14 4WK KIT US
• 00643169513631: EXT CARDIAC MON SEEQ13 3WK KIT US
• 00643169513600: EXT CARDIAC MON SEEQ12 2WK KIT US
• 00643169513570: EXT CARDIAC MON SEEQ11 1WK KIT US
• 00763000065744: EXT CARDIAC SEEQ14 4WK KIT US PHAR TUV
• 00763000065737: EXT CARDIAC SEEQ13 3WK KIT US PHAR TUV
• 00763000065669: EXT CARDIAC SEEQ1E SEN US PHAR TUV
• 00763000065652: EXT CARDIAC SEEQ1T TRAN US PHAR TUV
• 00763000065645: EXT CARDIAC SEEQ12 2WK KIT US PHAR TUV
• 00763000065638: EXT CARDIAC SEEQ11 1WK KIT US PHAR TUV
• 00763000057213: EXT CARDIAC SEEQ14 4WK KIT US TUV
• 00763000057206: EXT CARDIAC SEEQ13 3WK KIT US TUV
• 00763000057190: EXT CARDIAC SEEQ12 2WK KIT US TUV
• 00763000057176: EXT CARDIAC SEEQ1E SENSOR US TUV
• 00763000057152: EXT CARDIAC SEEQ1T TRANS US TUV
• 00763000057138: EXT CARDIAC SEEQ11 1WK KIT US TUV